Ignite Creation Date:
2024-05-06 @ 7:50 PM
Last Modification Date:
2024-10-26 @ 3:15 PM
Study NCT ID:
NCT06159257
Status:
RECRUITING
Last Update Posted:
2024-04-15
First Post:
2023-11-17
Brief Title:
Evaluation of the Physiological Stability Variability and Robustness of NIS4
Sponsor:
CerbaXpert
Organization:
CerbaXpert
Study Overview
Official Title:
Evaluation of the Physiological Stability Variability and Robustness of NIS4a Serum Biomarker for the Diagnosis of Non-alcoholic Steaohepatitis
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Patients at higher risk of progression to cirrhosis and clinical deleterious outcomes are those that have a high grade of necroinflammation together with significant fibrosis This defines a level of disease severity which is called at-risk NASH Currently registrational trials for NASH include only patients with at-risk NASH so it is predictable that when a drug will be approved for NASH it will be in patients with at-risk NASH It is therefore important to be able to diagnose non-invasively patients with at-risk NASH Also the use of NIS4 in clinical trials or in the clinic has the potential to significantly reduce unnecessary liver biopsies by identifying patients with a lower risk of disease progression GENFIT a late-stage biopharmaceutical company dedicated to improving the lives of patients with metabolic and chronic liver diseases is developing an in vitro diagnostic test for at-risk NASH The test is calledNIS4 and integrates four independent biomarkers - miR-34a-5p A2M YKL-40 and HbA1c The output is a score from 0 to 1 with threshold values that identify patients at low risk and high risk of at-risk NASH with intermediate values representing indeterminate results The objective of the program is to complete the development of the predictive and usable NIS4 score and to evaluate the impact of fasting or not fasting on the physiological stability variability and robustness of circulating biomarkers for the diagnosis of non-alcoholic steatohepatitis over a 30-day period
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None